CClinicalTrials.gg
CompletedNCT01960140Updated Jun 6, 2017Results posted

A Study of Baricitinib and Simvastatin in Healthy Participants

A Phase 1 interventional study of Baricitinib and Simvastatin in Healthy Volunteers, sponsored by Eli Lilly and Company. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-06.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purposes of this study are to determine the effects of baricitinib on the time it takes to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is when given alone and in combination with simvastatin. Side effects will be documented. The study will last approximately 7 days from the first dose to the end of the study (not including screening or follow-up).

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male participants - Agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
  • Female participants - Women not of childbearing potential due to surgical sterilization confirmed by medical history, or menopause
  • Have a body mass index of 18.0 to 29.0 kilograms per meter squared (kg/m\^2), inclusive
  • Have clinical laboratory test results within the normal reference range
  • Have normal renal function
  • Have normal blood pressure and pulse rate

Exclusion criteria

Exclusion Criteria:

  • Are currently enrolled in a clinical trial involving a study drug or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research
  • Have completed or discontinued within the last 90 days from a clinical trial involving a study drug
  • Have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib
  • Have known allergies to baricitinib, simvastatin, related compounds, or any components of the baricitinib or simvastatin formulations, or history of significant atopy
  • Have an abnormality in the 12-lead electrocardiogram (ECG)
  • Have a history of, or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (including hypothyroidism), hematological, or neurological disorders
  • Have current or recent history of myalgia or muscle weakness
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
  • Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
  • Have an absolute neutrophil count (ANC) less than 2 × 10\^9/liters (L) [2000 cells/microliter (μL)] at screening or day prior to first dose of study drug. For abnormal values, a single repeat will be allowed
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of hepatitis C infection and/or positive hepatitis C antibody
  • Show evidence of hepatitis B infection and/or positive hepatitis B surface antigen
  • Are women who are lactating
  • Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
  • Intend to use over-the-counter or prescription medication (including salicylate drugs) and/or herbal supplements within 14 days prior to dosing and during the study or intended use of vitamin supplements from Day 1 until discharge from the Clinical Research Unit (CRU)
  • Have consumed or intend to consume grapefruit or grapefruit-containing products within 14 days prior to the first dose and throughout the study
  • Have donated or lost blood of more than 500 milliliters (mL) within the last 3 months
  • Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to the first dose until discharge from the CRU at the end of Period 2
  • History of, in the opinion of the investigator, excessive methylxanthine use within the previous 6 months, such as greater than (>)6 cups of coffee (or equivalent) per day
  • Currently smoke more than 10 cigarettes per day
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Simvastatin

    Single oral dose of 40 milligrams (mg) simvastatin on Day 1.

    Drug: Simvastatin

  • Experimental
    Baricitinib + Simvastatin

    Oral doses of 10 mg baricitinib once daily (QD) on Days 3 to 7, with a single oral dose of 40 mg simvastatin coadministered on Day 6.

    Drug: Baricitinib · Drug: Simvastatin

Interventions

  • DrugBaricitinib

    Administered orally

    Also known as: LY3009104

  • DrugSimvastatin

    Administered orally

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid

    The Cmax of simvastatin \[a cytochrome P450 (CYP) 3A substrate\] and its active acid metabolite (simvastatin acid) is reported.

    Time frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose

  2. PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid

    The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.

    Time frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose

07

Results

Posted Apr 21, 2017

Participant flow

Period 1 (Days 1-2)
Participant flow — Period 1 (Days 1-2)
MilestoneSimvastatin Then Baricitinib and Simvastatin
Started40
Received simvastatin40
Completed40
Not completed0
Period 2 (Days 3-18)
Participant flow — Period 2 (Days 3-18)
MilestoneSimvastatin Then Baricitinib and Simvastatin
Started40
Received at least 1 dose of baricitinib40
Received simvastatin38
Completed38
Not completed2
Withdrew: Adverse event2

Outcome measures

PrimaryPharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid

The Cmax of simvastatin \[a cytochrome P450 (CYP) 3A substrate\] and its active acid metabolite (simvastatin acid) is reported.

Time frame:
Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose
Reported as:
Geometric mean · nanograms per milliliter (ng/mL)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid
nanograms per milliliter (ng/mL)SimvastatinBaricitinib and Simvastatin
Simvastatin6.85 ± 744.65 ± 57
Simvastatin Acid1.93 ± 681.60 ± 50
PrimaryPK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid

The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.

Time frame:
Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose
Reported as:
Geometric mean · nanograms*hour/milliliter (ng*h/mL)
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid
nanograms*hour/milliliter (ng*h/mL)SimvastatinBaricitinib and Simvastatin
Simvastatin (n=39, 36)40.7 ± 8633.7 ± 75
Simvastatin Acid (n=33, 32)26.4 ± 8121.0 ± 64

Adverse events

Collected over Baseline through study completion (up to Day 18). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Simvastatin—0/40 (0%)3/40 (7.5%)
Baricitinib—0/40 (0%)1/40 (2.5%)
Baricitinib and Simvastatin—0/38 (0%)3/38 (7.9%)
Most frequent other events
Most frequent other events
EventSimvastatinBaricitinibBaricitinib and Simvastatin
HeadacheNervous system disorders3/401/401/38
NasopharyngitisInfections and infestations0/400/402/38

Baseline characteristics

All enrolled participants.

Age, Continuous
Age, Continuous(years)Simvastatin Then Baricitinib and Simvastatin
Mean40.0 ± 13.0
Sex: Female, Male
Sex: Female, Male(Participants)Simvastatin Then Baricitinib and Simvastatin
Female5
Male35
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Simvastatin Then Baricitinib and Simvastatin
Hispanic or Latino0
Not Hispanic or Latino40
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Simvastatin Then Baricitinib and Simvastatin
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White39
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Simvastatin Then Baricitinib and Simvastatin
United Kingdom40
08

Study locations

1 site
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Leeds, West Yorkshire LS2 9LH, United Kingdom
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01960140
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 10, 2013
Start date
Oct 2013
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Apr 21, 2017
Last update
Jun 6, 2017

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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